DiaSorin Ireland Ltd.
⚠️ Moderate Risk
FEI: 3002806536 • Dublin • IRELAND
FEI Number
3002806536
Location
Dublin
Country
IRELANDAddress
Unit 13-14, Holly Avenue, , Dublin, , Ireland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2011 | 83GQNANTIGEN, CF (INCLUDING CF CONTROL), HERPESVIRUS HOMINIS 1,2 | New Orleans District Office (NOL-DO) | |
| 9/13/2002 | 88LDTREAGENT, GENERAL PURPOSE | 78STERILITY | New Orleans District Office (NOL-DO) |
| 1/6/2002 | 88LDTREAGENT, GENERAL PURPOSE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 1/6/2002 | 88LDTREAGENT, GENERAL PURPOSE | 78STERILITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is DiaSorin Ireland Ltd.'s FDA import refusal history?
DiaSorin Ireland Ltd. (FEI: 3002806536) has 4 FDA import refusal record(s) in our database, spanning from 1/6/2002 to 3/11/2011.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. DiaSorin Ireland Ltd.'s FEI number is 3002806536.
What types of violations has DiaSorin Ireland Ltd. received?
DiaSorin Ireland Ltd. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about DiaSorin Ireland Ltd. come from?
All FDA import refusal data for DiaSorin Ireland Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.